Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBicetre Hospital
About this trial
Acute respiratory distress syndrome (ARDS) is an inflammatory injury of the lungs caused by various serious illnesses, such as a bacterial or viral lung infection. It is treated by artificial ventilation with the application of positive pressure. Pulmonary injury, coupled with artificial ventilation, can lead to right heart failure which hinders the ejection of blood to the pulmonary circulation. Modern mechanical ventilation modalities have reduced the frequency ("incidence") of this right heart failure in acute respiratory distress syndrome. A large-scale study has shown this a few years ago. However, the evolution of right heart failure during artificial ventilation, and the consequences it has on the patient's cardiovascular status are poorly determined. This study is conducted to improve knowledge in this area. In adult patients hospitalized in intensive care presenting acute respiratory distress syndrome, the investigators will collect the data recorded on cardiac ultrasound, doses of cardiovascular drugs as well as variables reflecting hemodynamic status and cell oxygenation. Data will be collected during the course of ARDS and mechanical ventilation, as well as after weaning from artificial ventilation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old
Hospitalization in intensive care undergoing mechanical ventilation
Presence of ARDS according to the current consensus definition (Berlin definition)
Performance of at least one echocardiography during the first 24 hours of treatment, between the 2nd and 3rd day, between the 5th and 7th day, and within 48 hours of extubation
Disqualifiers
None
Trial population
* Hospitalization in intensive care * Age ≥18 years * Patients under mechanical ventilation * Presence of acute respiratory distress syndrome according to the Berlin definition
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Patients with ARDS under mechanical ventilation
Trial outcomes
Primary outcomes
1
Incidence and evolution of right heart failure during ARDS
Interpretation of echocardiography during the first 24 hours of treatment, between the 2nd and 3rd day, between the 5th and 7th day and after extubation.
Time frame
From enrollment to the end of the treatment at 8 weeksSecondary outcomes
1
The temporal evolution of the haemodynamic status
Describe the temporal evolution of hemodynamic status, assessed by changes in cardiovascular medication use (type and dose of vasopressors and inotropes, including norepinephrine µg/kg/min or vasopressin U/min) and tissue oxygenation variables from blood samples (including lactate mmol/l and ScvO2, %) on the same days as the echocardiography.
Time frame
From enrollment to the end of treatment at 8 weeks2
Phenotypic description of patients affected by right heart failure during ARDS
Identification and description of different phenotypes of RV failure in ARDS based on data from ultrasound, haemodynamic and tissue oxygenation characteristics the same day of echocardiography
Time frame
From enrollment to the end of treatment at 8 weeks3
Association of these different phenotypes with the prognosis
Time frame
From enrollment to the end of the treatment at 8 weeks4
Describe the risk factors for the occurrence of different phenotypes of right heart failure during ARDS
To describe the risk factors for the ocurrence of different phenotypes of right heart failure during ARDS, based on hemodynamic status including systemic and pulmonary arterial pressure (mmHg), medication use (type and dose of vasopressors and inotropes, including norepinephrine µg/kg/min or vasopressin U/min) and tissue oxygenation variables from blood samples (including lactate mmol/l and ScvO2, %), as well as echocardiographic assessment.
Time frame
From enrollment to the end of treatment at 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bicetre Hospital
Lead sponsor
Tenon Hospital, Paris
Collaborator
Hôpital Cochin
Collaborator
Henri Mondor University Hospital
Collaborator
Humanitas Hospital, Italy
Collaborator
Source ClinicalTrials.gov